Feasibility and Acceptability of a Motivational Interviewing–Based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening: Protocol for a Sequential Explanatory Mixed Methods Study

Background Gay, bisexual, and other men who have sex with men living with HIV (GBMSM-LWH) in the United States bear a heavy burden of bacterial sexually transmitted infections (STIs). Timely diagnosis and treatment are key to prevention. Only a few studies have combined home specimen self-collection for bacterial STI screening with live audio and video (AV) conferencing. None have focused on GBMSM-LWH or incorporated motivational interviewing (MI), a client-centered, strengths-based counseling approach that seeks to support individuals to create positive behavioral change. Objective Our study seeks to investigate the feasibility and acceptability of an MI-based telehealth intervention that integrates home specimen self-collection from different anatomical sites of possible exposure and MI delivered via live AV conferencing to engage sexually active GBMSM-LWH in bacterial STI screening. Methods Participants are being recruited from across the United States via advertising on mobile dating apps and social networking sites and via peer referral. Phase 1 involves piloting the delivery of an innovative telehealth intervention for bacterial STI screening to 75 GBMSM-LWH. Our intervention includes three components: (1) a pretest live AV conferencing session involving an MI-guided discussion to elicit awareness of bacterial STIs; fill any knowledge gaps; bolster the perceived importance of regularly testing for gonorrhea, chlamydia, and syphilis; and build self-efficacy for specimen self-collection; (2) home self-collection and return via mail of a urine sample (for gonorrhea and chlamydia testing), a throat swab (for gonorrhea and chlamydia testing), a rectal swab (for gonorrhea and chlamydia testing), and a finger-stick blood sample (for syphilis testing); and (3) a posttest live AV conferencing session involving an MI-guided discussion to prepare participants for receiving test results and formulate personalized action plans for seeking treatment (if warranted) and repeat testing. Descriptive statistics and progression ratios will be calculated, and potential variations in our intervention’s feasibility and acceptability will be numerically summarized and graphically visualized. Phase 2 involves elucidating attitudes, facilitators, and barriers related to engaging in each intervention component via semistructured in-depth interviews with a purposive subsample of 20 participants who complete progressively smaller subsets of the pretest session, specimen return for bacterial STI testing, and the posttest session. Thematic analysis will be used to identify, analyze, and report patterns in the data. Quantitative and qualitative data will be integrated at the design, methods, interpretation, and reporting levels. Results Study procedures were approved by the Institutional Review Board at the University of Michigan in September 2023. Participant recruitment began in April 2024. Conclusions Our study will advance multiple goals of the STI National Strategic Plan for the United States for 2021 to 2025, specifically those pertaining to preventing new STIs; accelerating progress in STI research, technology, and innovation; and reducing STI-related health disparities. Trial Registration ClinicalTrials.gov NCT06100250; https://www.clinicaltrials.gov/study/NCT06100250 International Registered Report Identifier (IRRID) DERR1-10.2196/64433


DESCRIPTION (provided by applicant):
Gay, bisexual and other men who have sex with men living with HIV (GBMSM-LWH) bear a heavy burden of bacterial sexually transmitted infections (STIs) such as gonorrhea (GC), chlamydia (CT) and syphilis.Left untreated, bacterial STIs may lead to serious health complications.Inflammatory and ulcerative STIs can also facilitate the onward sexual transmission of HIV in the presence of inadequate viral suppression.Timely diagnosis and treatment are key to prevention.Sexually active GBMSM-LWH engaged in HIV medical care are not being screened for GC, CT and syphilis at least annually, as recommended.Home specimen self-collection has increasingly been used to screen for bacterial STIs in studies conducted with diverse populations.Telehealth has also demonstrated promise in managing mental health and increasing antiretroviral therapy adherence in people living with HIV.Only few studies have combined home specimen selfcollection with live audio/video (AV) conferencing, all of which have been restricted to people without HIV.None have focused on GBMSM-LWH or incorporated motivational interviewing (MI), a clientcentered, strengths-based counseling approach that seeks to support individuals towards positive behavioral change.Integrating home specimen self-collection from different anatomical sites of possible exposure with MI delivered via live AV conferencing might offer a unique solution to engage GBMSM-LWH in bacterial STI screening.MI-guided discussions have the potential to increase participants' knowledge of bacterial STIs, enhance their intrinsic motivation to protect themselves and their sex partners, improve their self-efficacy for specimen self-collection, and problem-solve barriers to seeking treatment (if warranted) and repeat testing.Our sequential explanatory mixed-methods study seeks to explore the feasibility and acceptability of a novel MI-based telehealth intervention for sexually active GBMSM-LWH.In Phase 1, we will recruit 75 participants via mobile dating apps and social networking websites, and deliver a 3-component intervention: (i) a pre-test live AV conferencing session involving an MI-guided discussion to elicit awareness of bacterial STIs and fill any knowledge gaps, bolster the perceived importance of regularly screening for GC, CT and syphilis, and improve self-efficacy for specimen self-collection, (ii) self-collecting at home and returning by mail a finger-stick blood sample (for syphilis testing), a urine sample (for GC and CT testing), a pharyngeal swab (for GC and CT testing) and a rectal swab (for GC and CT testing), and (iii) a post-test live AV conferencing session involving an MI-guided discussion to prepare participants for receiving test results and formulate personalized action plans for seeking treatment (if warranted) and repeat testing.In Phase 2, we will conduct in-depth interviews with a purposively selected subsample of 20 participants who complete progressively smaller subsets of the pre-test session, specimen return for bacterial STI testing, and the post-test session to elucidate attitudes, facilitators and barriers related to engaging in each component of our intervention.

PUBLIC HEALTH RELEVANCE:
Despite an increase in home specimen self-collection for bacterial sexually transmitted infection (STI) screening in studies conducted with diverse populations, and the demonstrated promise of telehealth in managing mental health and improving antiretroviral therapy adherence in people living with HIV, no studies have combined home specimen self-collection with live audio/video (AV) conferencing to deliver motivational interviewing (MI), a client-centered, strengthsbased counseling approach.Our sequential explanatory mixed-methods study seeks to explore the feasibility and acceptability of a novel MI-based telehealth intervention to engage sexually active gay, bisexual and other men who have sex with men living with HIV (GBMSM-LWH) in gonorrhea (GC), chlamydia (CT) and syphilis screening.Our intervention is a package of 3 components: (i) a pre-test live AV conferencing session involving an MI-guided discussion to elicit awareness of bacterial STIs and fill any knowledge gaps, bolster the perceived importance of regularly screening for GC, CT and syphilis, and improve self-efficacy for specimen self-collection, (ii) self-collecting at home and returning by mail a finger-stick blood sample (for syphilis testing), a urine sample (for GC and CT testing), a pharyngeal swab (for GC and CT testing) and a rectal swab (for GC and CT testing), and (iii) a post-test live AV conferencing session involving an MI-guided discussion to prepare participants for receiving test results and formulate personalized action plans for seeking treatment (if warranted) and repeat testing.

CRITIQUE 1
Significance: 1 Investigator(s): 1 Innovation: 4 Approach: 1 Environment: 1 Overall Impact: This highly responsive resubmission will investigate the feasibility and acceptability of a novel motivational interviewing (MI)-based telehealth intervention to engage gay and bisexual men who have sex with men living with HIV in GC, CT and syphilis screening.The 2-year sequential explanatory mixed-methods project contains 3 components: a pre-test live AV conference, selfcollecting STI testing at home and returning by mail, and a post-test live AV conferencing session involving an MI-guided discussion.This superbly detailed proposal contains strongly positive score driving aspects in all categories.The target population is in need with high rates of bacterial STIs.The work is theoretically grounded.The investigators are exceptionally well qualified with deep experience in expanding STI testing with novel approaches and motivational interviewing in marginalized populations.The team is slim and highly accomplished.The work is innovative combining three approaches: home specimen self-collection of blood, urine, and rectal sampling, motivational interviewing-guided discussions over live AV conferencing.The approach is rigorous using validated measures and over recruitment of minority populations is a further strength.The U of M environment is exceptionally supportive.The prior minor score driving considerations have been overcome as they now experience recruiting from online sources AND engaging those participants in at-home self-testing.This is highly positively score driving.The innovation is limited to the combination of the three study components.Overall, this is a very well designed study that has a high likelihood of advancing the field in an area of need.

Strengths
• U.S. The incidence of GC, chlamydia, and syphilis in this population is extraordinarily high (7-12% positive testing rate for each) though the proportion of the population getting tested is low.
• Barriers to testing have been identified.
• The Infectious Diseases Society of America supports using telehealth to deliver "up-to-date, timely, cost-effective" care to marginalized populations and motivational interviewing improves health behaviors of those living with HIV but has not been adequately tested in the target population nor to increase bacterial STI testing.
• The rigor or prior research support development of this intervention in this population.

Weaknesses
• None noted by reviewer

Strengths
• The PI has an established record of first authorship on new approaches to STI testing and selftesting across gender identities.The addition of an established expert in motivational interviewing (for Aim 1) with a history of NIH funding also strongly and favorably impacts the proposal.
• Highlighting the PI experience in leading an NIH-funded mixed-methods study and the Co-I's history of qualitative research is responsive and positively score driving.

Weaknesses
• None noted by reviewer

Strengths
• The combination of integrating home specimen self-collection for syphilis and triple-site GC and CT testing with MI-guided discussions over live AV conferencing is innovative.

Weaknesses
• Individually the components lack innovation.

Strengths
• The recruited population will mirror the current U.S. racial/ethnic distribution of GBMSM-LWH in the US.
• Support for the data collection approaches (such as self-report of HIV testing and results) is supported by prior work.
• Rigorous and validated measures of feasibility and acceptability are included.The mixed method design seems particularly appropriate for testing an intervention at this level of maturity.
• The addition of specific go/no-go criteria for the Aim 1 findings is responsive and increases the rigor of the work.
• The use of specimen self-collection kits and instructions provided by the same Emory lab used for this project in over a dozen studies including work by these investigators supports feasibility.As does preliminary data from recent NIH-funded studies that successfully implemented online recruitment, home specimen self-collection and telehealth-delivered MI.

Weaknesses
• None noted by reviewer • The target population limits participation to a sub-population of those who identify as men and oversamples for those from racial and ethnic minority groups

Resubmission
• This is a highly responsive resubmission with close attention.

CRITIQUE 2
Significance: 1 Investigator(s): 1 Innovation: 1 Approach: 1 Environment: 1 Overall Impact: This is a resubmission of a R21 proposal focused on evaluating the feasibility and acceptability of a telehealth intervention for bacterial STI screening among GBMSM-LWH in the US.This was a well written application with excellent preliminary data from prior work in a similar population, excellent data supporting the research team's success in recruiting from social media platforms, a sound conceptual framework and a highly experienced research team.There were no significant weaknesses in the application.Thus, findings from this research will be sure to have a sustained impact in the field.

Strengths
• GBMSM-LWH bear a heavy burden of bacterial sexually transmitted infections (STIs) such as gonorrhea (GC), chlamydia (CT) and syphilis.Left untreated, bacterial STIs can result in serious health complications and can facilitate the transmission of HIV without adequate viral suppression.

Weaknesses
• None noted by reviewer

Investigator(s):
Strengths • Dr. Sharma is an infectious disease epidemiologist whose research focuses on engaging vulnerable populations such as GBMSM in HIV and STI prevention activities including the use of telehealth to overcome some of these barriers.
• He has prior research experience in this area as PI on a NIH-funded study (Project Caboodle) evaluating the acceptability and feasibility of specimen self-collection for STIs among high-risk populations.
• Dr. Bonar is a psychologist who has extensive clinical training in MI and has research expertise in qualitative methods.

Weaknesses
• None noted by reviewer

Strengths
• Home specimen self-collection for GC, CT and syphilis testing combined with MI-guided education and discussions over live AV conferencing brings innovation to the proposal.
• Evaluated the feasibility of this combined intervention in the population of sexually active GBMSM-LWH is also highly significant and innovative.

Weaknesses
• None noted by reviewer

Strengths
• In Project Caboodle, PI Sharma enrolled a diverse sample of 100 GBMSM without HIV via Grindr and Facebook (63% were racial/ethnic minorities): 51% of participants returned selfcollected specimens for HIV, GC, CT and potential PrEP adherence testing in ≤6 weeks without MI, incentives or reminders.In other studies, they enrolled 81 GBMSM-LWH in 10 days and 147 GBMSM-LWH in 4 weeks solely via Facebook.
• Emails and mobile phone numbers will be verified via required response to a test email and text.Individuals who do not consent, do not meet the eligibility criteria or do not provide valid contact information will be excluded and directed to the CDC's website on STI prevention.
• Survey constructs and measures were appropriate and described in detail.
• For participants receiving a positive GC, CT or syphilis test result, the clinical pathways that will occur to provide them and their partner with timely treatment were described.
• All videoconferencing sessions will be audio recorded to assess MI fidelity.
• Pilot outcomes (i.e., intervention feasibility, acceptability, knowledge, STI prevalence, receipt of treatment) were well described and appropriate for the proposed research.
• Purposive sampling will be used for qualitative interviews to select a mix of participants who complete progressively smaller subsets of the pre-test session, specimen return for bacterial STI testing, and the post-test session.
• Approach to qualitative analysis is appropriate and integration of qualitative and quantitative findings is well described.

Weaknesses
• None noted by reviewer

Strengths
• The University of Michigan is home to the Center for Sexuality and Health Disparities which offers resources specific to sexuality research.They will support the qualitative components of the research.
• Investigators will partner with the Emory University Clinical Virology Research Lab (CVRL) which will provide self-collection kits for the study and analyze the samples.This lab is CLIAcertified so results can be used to determine treatment needs.

Resubmission
• The application was highly responsive to the prior critiques.

Resource Sharing Plans
Not Applicable (No Relevant Resources)

CRITIQUE 3
Significance: 2 Investigator(s): 1 Innovation: 3 Approach: 2 Environment: 1 Overall Impact: This is a resubmitted application proposes to use a mixed-methods approach to examine the feasibility and acceptability of a motivational interviewing intervention to promote better STI screening in GBMSM-LWH.This is a well-written proposal and a significant area of study.The research team is strong and experienced.Prior critiques were positive with some concerns that have been addressed by the investigators.Increased attention to and plans for providing answers to specific participant concerns is an added strength.Overall, the proposed work is likely to have a high impact.

Strengths
• Addressing known barriers to STI screening.
• Theory based proposal.
• Use of MI, a known successful technique.

Weaknesses
• No significant weaknesses.

Strengths
• The PI has a strong track record in work proposed.
• The supporting team has the necessary expertise to successfully complete this project.

Weaknesses
• None noted by reviewer.

Strengths
• The home-based screening of STI with proposed intervention is innovative.

Weaknesses
• In general, study design and intervention approaches are appropriate though have been used in other settings/populations.

Strengths
• Mixed methods design.
• Sample size is justified.
• Surveys are appropriate to study questions.

Weaknesses
• Intervention may not address all barriers to screening.

Strengths
• Exceptionally strong environment (Emory and Michigan) for the proposed work.

Weaknesses
• None noted by reviewer.

Strengths
• Timeline is appropriate.

Weaknesses
• None noted by reviewer.

Protections for Human Subjects
Acceptable Risks and/or Adequate Protections Footnotes for 1 R21 AI168606-01A1; PI Name: Sharma, Akshay NIH has modified its policy regarding the receipt of resubmissions (amended applications).See Guide Notice NOT-OD-18-197 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html.The impact/priority score is calculated after discussion of an application by averaging the overall scores (1-9) given by all voting reviewers on the committee and multiplying by 10.The criterion scores are submitted prior to the meeting by the individual reviewers assigned to an application, and are not discussed specifically at the review meeting or calculated into the overall impact score.Some applications also receive a percentile

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The U of Michigan provides extraordinary resources including in this case the Center for Sexuality and Health Disparities within the School of Nursing.STI testing will be sent to the Emory University Clinical Virology Research Lab which is extremely well-equipped to conduct this testing.None noted by reviewerProtections for Human SubjectsAcceptable Risks and/or Adequate Protections• Extensive precautions are in place to protect the participants and their data.Data and Safety Monitoring Plan (Applicable for Clinical Trials Only):Acceptable o The investigators will monitor the data for Aes and SAEs and will form a DSMB.Inclusion Plans• Sex/Gender: Distribution justified scientifically • Race/Ethnicity: Distribution justified scientifically• For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable • Inclusion/Exclusion Based on Age: Distribution justified scientifically

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Race/Ethnicity: Distribution justified scientifically• For NIH-Defined Phase III trials, Plans for valid design and analysis:• Inclusion/Exclusion Based on Age: Distribution justified scientifically Critiques from prior review have been adequately addressed.
None noted by reviewer

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For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable